European Committee Approves Opdivo Advance

Opdivo Advances in Europe


In response to the decision made in the United States last March, manufacturer Bristol-Myers Squibb has announced a new dosing schedule for Opdivo (nivolumab), recommended by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

This new dosing schedule lets physicians choose to prescribe Opdivo as a 480 mg dose given monthly, or as a 240 mg dose given every two weeks. The medication is set to treat advanced melanoma and previously treated renal cell carcinoma.

For the 480 mg management, 60 minutes is the advised infusion time while an infusion session of only 30 minutes is advised for the 240 mg regimen. This recommendation by CHMP will be evaluated by the European Commission.

After conducting a study on Opdivo’s safety and effectiveness, the U.S. Food and Drug Administration approved the new dosing schedule.The study’s findings were introduced at the American Association for Cancer Research Annual Meeting 2017, in a symposium entitled “A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types.”

These findings compared results of patients with melanoma, advanced non–small cell lung cancer (NSCLC), or advanced renal cell carcinoma who were treated with different dosages (480 mg on the 4-week regimen and 240 mg on a 2-week dosing) all shared similar predicted objective tumor responses despite the difference in dosage and frequency. It was also concluded that all patients shared similar survival rates at one and two years.

As part of two Phase 3 clinical trials, the new 480 mg with a 4-week regimen is currently undergoing evaluation, recruiting up to 620 participants, divided into two trials: one for advanced melanoma and one for advanced or metastatic NSCLC.